New Webinar: Streamlining the Regulatory Path to Market for Low-Risk Medical Devices

By Emily Nichols / January 13, 2015

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Medical devices are a highly diverse group of products, and the processes for their regulatory review and clearance are variable. Lower-risk devices (Class I and II) generally require less time and expense to meet the FDA’s standards for safety and efficacy than Class III devices, but meeting the standards that do exist can be complex.

Developing a high-level strategy for meeting regulatory requirements and implementing a QSR compliant quality system early in a product’s lifecycle can save resources and improve the device’s safety and performance in patients.

Our medical device expert:
Charlotte Baker, RAC, PMPSenior Director, Regulatory & Strategic Development, Medical Devices, Clinipace WorldwideCharlotte brings more than 20 years experience in regulatory, quality and compliance in the healthcare, biopharma and medical device industries. She also has a proven track record in leading and achieving successful global product submissions/approvals for new products and post-commercialization changes (PMA & 510k). In her current role, Charlotte is responsible for developing regulatory strategies for client products. She also prepares regulatory submissions for the US FDA, EMEA and other regulatory authorities.

Register today to reserve your spot. Even if you can’t attend the live presentation, register anyway and we’ll send you a link to the recording! Also keep an eye out for an accompanying eBook to follow the webinar.

When you have clinical research and development questions, the answer is Clearly Clinipace.

At Clinipace, a global, full-service contract research organization (CRO), our approach to clinical research is personal. We deliver a level of collaboration and flexibility not possible in a traditional CRO environment. With personalized services and solutions, local regulatory expertise and therapeutic leadership, we overcome the most difficult industry challenges across all major therapeutic areas including oncology, gastroenterology, and nephrology and urology. We strive to improve the way clinical research is performed and impact the future of health care using the most advanced technology and a CHALLENGE ACCEPTED approach.